Open Pivot™

GUDID 00643169334809

MHV 500DM35 STD MITRAL

MEDTRONIC, INC.

Mitral bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 00643169334809
• NIH Device Record Key: 3192f3e3-27fd-4182-a768-3a78ea34a063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Open Pivot™
• Version Model Number: 500DM35
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169334809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990046

FDA Product Code

• LWQ: HEART-VALVE, MECHANICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [Open Pivot™]

• 00613994869050: MHV 500DM35 STD MITRAL
• 00613994869043: MHV 500FA29 STD AORTIC
• 00613994869036: MHV 500FA27 STD AORTIC
• 00613994869029: MHV 500FA25 STD AORTIC
• 00613994869012: MHV 500FA23 STD AORTIC
• 00613994869005: MHV 500FA21 STD AORTIC
• 00613994868992: MHV 500FA19 STD AORTIC
• 00613994868985: MHV 500DM31 STD MITRAL
• 00613994868978: MHV 500DM29 STD MITRAL
• 00613994868961: MHV 500DM27 STD MITRAL
• 00613994868954: MHV 501DA16 AP AORTIC
• 00613994868947: MHV 500DM33 STD MITRAL
• 00613994868930: MHV 500DM31 STD MITRAL
• 00613994868923: MHV 500DM29 STD MITRAL
• 00613994868916: MHV 500DM27 STD MITRAL
• 00613994868893: MHV 505DA26 AP360
• 00613994868886: MHV 505DA24 AP360
• 00613994868879: MHV 505DA22 AP360
• 00613994868862: MHV 505DA20 AP360
• 00613994868855: MHV 505DA18 AP360
• 00613994868848: MHV 505DA16 AP360
• 00613994868800: MHV 501DA18 AP AORTIC
• 00613994868794: MHV 500DM25 STD MITRAL
• 00613994868787: MHV 500FA29 STD AORTIC
• 00613994868770: MHV 500FA27 STD AORTIC
• 00613994868756: MHV 500FA23 STD AORTIC
• 00613994868749: MHV 500FA21 STD AORTIC
• 00613994868732: MHV 500FA19 STD AORTIC
• 00613994868725: MHV 501DM28 AP MITRAL
• 00613994868718: MHV 501DM26 AP MITRAL
• 00613994868701: MHV 501DM24 AP MITRAL
• 00613994868695: MHV 501DM22 AP MITRAL
• 00613994868688: MHV 501DA26 AP AORTIC
• 00613994868671: MHV 501DA24 AP AORTIC
• 00613994868664: MHV 501DA22 AP AORTIC
• 00613994868657: MHV 501DA20 AP AORTIC
• 00613994868633: MHV 503DA26 APEX AORTIC
• 00613994868626: MHV 503DA24 APEX AORTIC
• 00613994868619: MHV 503DA22 APEX AORTIC
• 00613994868602: MHV 503DA20 APEX AORTIC
• 00613994868596: MHV 503DA18 APEX AORTIC
• 00613994868589: MHV 503DA16 APEX AORTIC
• 00613994868374: AVG 502AG29 CONDUIT
• 00613994868367: AVG 502AG27 CONDUIT
• 00613994868350: AVG 502AG25 CONDUIT
• 00613994868343: AVG 502AG23 CONDUIT
• 00613994868336: AVG 502AG21 CONDUIT
• 00643169133464: AVG 502AG21 CONDUIT
• 00643169133457: AVG 502AG23 CONDUIT
• 00643169133440: AVG 502AG25 CONDUIT